| CTRI Number |
CTRI/2025/03/082581 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
IMMEDIATE EFFECT OF COLD AND NEUTRAL STREAM OF WATER OVER CHEST ON LUNG FUNCTION AMONG HEALTHY VOLUNTEERS
|
|
Scientific Title of Study
|
Immediate Effect Of Cold And Neutral Douche Over Thoracic
Region On Pulmonary Function Among Healthy Volunteers: A
Randomized Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakshitha K |
| Designation |
MD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire |
| Address |
Department of Natural Therapeutics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka
574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
7996186995 |
| Fax |
|
| Email |
dr.rakshithaborkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakshitha K |
| Designation |
MD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire |
| Address |
Department of Natural Therapeutics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka
574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
7996186995 |
| Fax |
|
| Email |
dr.rakshithaborkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geetha Kumari V |
| Designation |
Dean and Proffesor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire |
| Address |
Department Of Nutrition And Dietetics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka 574240 Dakshina Kannada KARNATAKA 574240 India |
| Phone |
9449714767 |
| Fax |
|
| Email |
Gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, Shantivana, Dharmasthala, Belthangady, Dakshina Kannada, Karnataka, India-574240 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshitha K |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka
574240 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakshitha K |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana |
COE Department of
Yoga and Therapeutics
Shantivana,
Dharmasthala,
Belthangadi, Dakshina
Kannada, Karnataka,
India - 574216
Dakshina Kannada
KARNATAKA Dakshina Kannada KARNATAKA |
7996186995
dr.rakshithaborkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold douche to thoracic area |
The treatment will be given in the treatment room using specially designed douche apparatus , which is attached with temperature and pressure controlling unit. The patient will be asked to stand 1.5m away from the aperture. The treatment will start from horizontal jet to shoulder and arms with high pressure approximately 40-50 PSI(pound per square inch) and with the cold temperature ranging from 15-22 degree celcius. Followed by broken jet to front and sides of the chest and ending with the horizontal jet to the back of the chest and vertebral prominences. The duration of the treatment is 10 seconds to each part that will be 1 minute in total. |
| Comparator Agent |
Neutral douche to thoracic area |
The treatment will be given in the treatment room using specially designed douche apparatus, which is attached with temperature and pressure controlling unit. The patient will be asked to stand 1.5m away from the aperture. The treatment will start from horizontal jet to shoulder and arms with high pressure approximately 40-50 PSI and with temperature ranging from 34-36 degree Celsius. Followed by broken jet to front and sides of the chest and ending with the horizontal jet to the back of the chest and vertebral prominences. The duration of the treatment is 10 seconds to each part that will be 1 minute in total. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age ranging from 18 to 30 years
Subjects Who Are Willing To Participate In The Study
Gender: Both Male And Female |
|
| ExclusionCriteria |
| Details |
Weak And Debilitating Individuals
Any Systemic Illness
Subjects With Open Wounds
Subjects Who Are Intolerant To Cold |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Forced vital capacity (FVC)
Forced expiratory volume at 1 second (FEV1)
Forced expiratory flow (FEF25-75%)
Peak expiratory flow (PEF) |
Pre, Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Naturopathy is a unique kind of primary care that
combines modern research and scientific advancements with age-old healing
practices. Fasting therapy, food therapy, hydrotherapy, massage therapy,
mud therapy, chromotherapy, and air therapy are examples of non-invasive
treatments.
Respiratory illness is linked to Autonomic nervous system
(ANS) imbalance. Two possible presentations of asthma include imbalances
between the parasympathetic and sympathetic nervous systems (PNS and SNS), or
hyperfunction of the PNS in the airways. Numerous naturopathic treatments can
be used to balance the autonomic nerve system. The number of people with
chronic respiratory diseases globally in 2017 was 544·9 million (95%
uncertainty range), which was a 39·8% rise from 1990.Localized douches can be utilized
to treat illnesses of the respiratory system. Early hydrotherapy textbooks
discuss how a brief cold application can aid to enhance lung function.
Currently only one evidence is published on neutral douche, and no evidence of
the effects of cold douche is currently available. Therefore, understanding how
cold douche affects thoracic rebound in pulmonary function will be aided by
this research. This will help to enhance the efficacy of hydrotherapeutic
techniques. |